Susceptibility breakpoints and target values for therapeutic drug monitoring of voriconazole and Aspergillus fumigatus in an in vitro pharmacokinetic/pharmacodynamic model

Journal of Antimicrobial Chemotherapy

Volumn 69, Issue 6, 2014, Pages 1611-1619

  Siopi, Maria ^a   Mavridou, Eleftheria ^b   Mouton, Johan W ^c,d   Verweij, Paul E ^c   Zerva, Loukia ^a   Meletiadis, Joseph ^a  

^a NATIONAL AND KAPODISTRIAN UNIVERSITY OF ATHENS   (Greece)

^b WEILL CORNELL MEDICAL COLLEGE   (United States)

^c RADBOUD UNIVERSITY MEDICAL CENTER   (Netherlands)

^d ERASMUS MEDICAL CENTER   (Netherlands)

Author keywords

A. fumigatus; Azole resistance; Trough levels

Indexed keywords

VORICONAZOLE; ANTIFUNGAL AGENT;

ANTIFUNGAL ACTIVITY; ANTIFUNGAL SUSCEPTIBILITY; AREA UNDER THE CURVE; ARTICLE; ASPERGILLUS FUMIGATUS; DRUG HALF LIFE; FUNGUS ISOLATION; GROWTH INHIBITION; IN VITRO STUDY; LUNG ASPERGILLOSIS; MAXIMUM PLASMA CONCENTRATION; MINIMUM INHIBITORY CONCENTRATION; MONTE CARLO METHOD; NONHUMAN; SURVIVAL RATE; ANIMAL; ASPERGILLOSIS; DISEASE MODEL; DRUG EFFECTS; DRUG MONITORING; HUMAN; MAXIMUM TOLERATED DOSE; MICROBIAL SENSITIVITY TEST; MOUSE; STATISTICAL MODEL;

ANIMALS; ANTIFUNGAL AGENTS; ASPERGILLOSIS; ASPERGILLUS FUMIGATUS; DISEASE MODELS, ANIMAL; DRUG MONITORING; HUMANS; MAXIMUM TOLERATED DOSE; MICE; MICROBIAL SENSITIVITY TESTS; MODELS, STATISTICAL; VORICONAZOLE;

EID: 84896998049     PISSN: 03057453     EISSN: 14602091     Source Type: Journal    
DOI: 10.1093/jac/dku023     Document Type: Article

References (51)

1. Walsh TJ, Anaissie EJ, Denning DW et al. Treatment of aspergillosis: clinical practice guidelines of the Infectious Diseases Society of America. Clin Infect Dis 2008; 46: 327-60.
2. Herbrecht R, Denning DW, Patterson TF et al. Voriconazole versus amphotericin B for primary therapy of invasive aspergillosis. N Engl J Med 2002; 347: 408-15.
3. Howard SJ, Cerar D, Anderson MJ et al. Frequency and evolution of azole resistance in Aspergillus fumigatus associated with treatment failure. Emerg Infect Dis 2009; 15: 1068-76.
4. Snelders E, Melchers WJ, Verweij PE. Azole resistance in Aspergillus fumigatus: a new challenge in the management of invasive aspergillosis? Future Microbiol 2011; 6: 335-47.
5. Baddley JW, Marr KA, Andes DR et al. Patterns of susceptibility of Aspergillus isolates recovered from patients enrolled in the Transplant-Associated Infection Surveillance Network. J Clin Microbiol 2009; 47: 3271-5.
6. Hope WW, Cuenca-Estrella M, Lass-Florl C et al. EUCAST technical note on voriconazole and Aspergillus spp. Clin Microbiol Infect 2013; 19: E278-80.
7. Jeans AR, Howard SJ, Al-Nakeeb Z et al. Pharmacodynamics of voriconazole in a dynamic in vitro model of invasive pulmonary aspergillosis: implications for in vitro susceptibility breakpoints. J Infect Dis 2012; 206: 442-52.
8. Meletiadis J, Mavridou E, Melchers WJ et al. Epidemiological cutoffvalues for azoles and Aspergillus fumigatus based on a novel mathematical approach incorporating cyp51A sequence analysis. Antimicrob Agents Chemother 2012; 56: 2524-9.
9. Capilla J, Clemons KV, Stevens DA. Animal models: an important tool in mycology. Med Mycol 2007; 45: 657-84.
10. Andes D. Use of an animal model of disseminated candidiasis in the evaluation of antifungal therapy. Methods Mol Med 2005; 118: 111-28.
11. Neofytos D, Horn D, Anaissie E et al. Epidemiology and outcome of invasive fungal infection in adult hematopoietic stem cell transplant recipients: analysis of Multicenter Prospective Antifungal Therapy (PATH) Alliance registry. Clin Infect Dis 2009; 48: 265-73.
12. Salas V, Pastor FJ, Calvo E et al. Evaluation of the in vitro activity of voriconazole as predictive of in vivo outcome in a murine Aspergillus fumigatus infection model. Antimicrob Agents Chemother 2013; 57: 1404-8.
13. Andes D, Pascual A, Marchetti O. Antifungal therapeutic drug monitoring: established and emerging indications. Antimicrob Agents Chemother 2009; 53: 24-34.
14. Bruggemann RJ, Donnelly JP, Aarnoutse RE et al. Therapeutic drug monitoring of voriconazole. Ther Drug Monit 2008; 30: 403-11.
15. Troke PF, Hockey HP, Hope WW. Observational study of the clinical efficacy of voriconazole and its relationship to plasma concentrations in patients. Antimicrob Agents Chemother 2011; 55: 4782-8.
16. Pascual A, Calandra T, Bolay S et al. Voriconazole therapeutic drug monitoring in patients with invasive mycoses improves efficacy and safety outcomes. Clin Infect Dis 2008; 46: 201-11.
17. Meletiadis J, Al-Saigh R, Velegraki A et al. Pharmacodynamic effects of simulated standard doses of antifungal drugs against Aspergillus species in a new in vitro pharmacokinetic/pharmacodynamic model. Antimicrob Agents Chemother 2012; 56: 403-10.
18. Al-Saigh R, Elefanti A, Velegraki A et al. In vitro pharmacokinetic/pharmacodynamic modeling of voriconazole activity against Aspergillus species in a new in vitro dynamic model. Antimicrob Agents Chemother 2012; 56: 5321-7.
19. Mavridou E, Bruggemann RJ, Melchers WJ et al. Impact of cyp51A mutations on the pharmacokinetic and pharmacodynamic properties of voriconazole in a murine model of disseminated aspergillosis. Antimicrob Agents Chemother 2010; 54: 4758-64.
20. Clinical and Laboratory Standards Institute. Reference Method for Broth Dilution Antifungal Susceptibility Testing of Filamentous Fungi-Second Edition: Approved Standard M38-A2. CLSI, Wayne, PA, USA, 2008.
21. EUCAST. Method for the Determination of Broth Dilution Minimum Inhibitory Concentrations of Antifungal Agents for Conidia Forming Moulds. http://www.eucast.org/fileadmin/src/media/PDFs/4ESCMID_ Library/3Publications/EUCAST_Documents/Other_Documents/EUCAST_ moulds_DEFINITIVE_document_V_ISO_April_08%20final.pdf (9 January 2014, date last accessed).
22. Siopi M, Gamaletsou M, Sipsas N et al. Determination of voriconazole levels in serum of hematological patents with a microbiological assay. B Hel Soc Microbiol 2013; 58: 1-9.
23. Purkins L, Wood N, Ghahramani P et al. Pharmacokinetics and safety of voriconazole following intravenous-to oral-dose escalation regimens. Antimicrob Agents Chemother 2002; 46: 2546-53.
24. Purkins L, Wood N, Greenhalgh K et al. The pharmacokinetics and safety of intravenous voriconazole-a novel wide-spectrum antifungal agent. Br J Clin Pharmacol 2003; 56 Suppl 1: 2-9.
25. Pfizer Inc. VFENDw (Voriconazole) United States Package Insert. New York: Pfizer Inc., 2010.
26. Espinel-IngroffA, Diekema DJ, Fothergill A et al. Wild-type MIC distributions and epidemiological cutoffvalues for the triazoles and six Aspergillus spp. for the CLSI broth microdilution method (M38-A2 document). J Clin Microbiol 2010; 49: 3251-7.
27. Trifilio S, Pennick G, Pi J et al. Monitoring plasma voriconazole levels may be necessary to avoid subtherapeutic levels in hematopoietic stem cell transplant recipients. Cancer 2007; 109: 1532-5.
28. Warn PA, Sharp A, Parmar A et al. Pharmacokinetics and pharmacodynamics of a novel triazole, isavuconazole: mathematical modeling, importance of tissue concentrations, and impact of immune status on antifungal effect. Antimicrob Agents Chemother 2009; 53: 3453-61.
29. Andes D, Marchillo K, Stamstad T et al. In vivo pharmacokinetics and pharmacodynamics of a new triazole, voriconazole, in a murine candidiasis model. Antimicrob Agents Chemother 2003; 47: 3165-9.
30. Andes D. Pharmacokinetics and pharmacodynamics of antifungals. Infect Dis Clin North Am 2006; 20: 679-97.
31. Capitano B, Potoski BA, Husain S et al. Intrapulmonary penetration of voriconazole in patients receiving an oral prophylactic regimen. Antimicrob Agents Chemother 2006; 50: 1878-80.
32. Heng SC, Snell GI, Levvey B et al. Relationship between trough plasma and epithelial lining fluid concentrations of voriconazole in lung transplant recipients. Antimicrob Agents Chemother 2013; 57: 4581-3.
33. Joukhadar C, Thallinger C, Poppl W et al. Concentrations of voriconazole in healthy and inflamed lung in rats. Antimicrob Agents Chemother 2009; 53: 2684-6.
34. de Araujo BV, da Silva CF, Haas SE et al. Free renal levels of voriconazole determined by microdialysis in healthy and Candida sp.-infected Wistar rats. Int J Antimicrob Agents 2009; 33: 154-9.
35. Wingard JR, Ribaud P, Schlamm HT et al. Changes in causes of death over time after treatment for invasive aspergillosis. Cancer 2008; 112: 2309-12.
36. Chandrasekar PH, Cutright J, Manavathu E. Efficacy of voriconazole against invasive pulmonary aspergillosis in a guinea-pig model. J Antimicrob Chemother 2000; 45: 673-6.
37. Petraitis V, Petraitiene R, Hope WW et al. Combination therapy in treatment of experimental pulmonary aspergillosis: in vitro and in vivo correlations of the concentration-and dose-dependent interactions between anidulafungin and voriconazole by Bliss independence drug interaction analysis. Antimicrob Agents Chemother 2009; 53: 2382-91.
38. Olson JA, Adler-Moore JP, Schwartz J et al. Comparative efficacies, toxicities, and tissue concentrations of amphotericin B lipid formulations in a murine pulmonary aspergillosis model. Antimicrob Agents Chemother 2006; 50: 2122-31.
39. Finlay GJ, Baguley BC. Effects of protein binding on the in vitro activity of antitumour acridine derivatives and related anticancer drugs. Cancer Chemother Pharmacol 2000; 45: 417-22.
40. Roffey SJ, Cole S, Comby P et al. The disposition of voriconazole in mouse, rat, rabbit, guinea pig, dog, and human. Drug Metab Dispos 2003; 31: 731-41.
41. Zeitlinger MA, Derendorf H, Mouton JW et al. Protein binding: do we ever learn? Antimicrob Agents Chemother 2011; 55: 3067-74.
42. Smith DA, Di L, Kerns EH. The effect of plasma protein binding on in vivo efficacy: misconceptions in drug discovery. Nat Rev Drug Discov 2010; 9: 929-39.
43. Elefanti A, Mouton JW, Krompa K et al. Inhibitory and fungicidal effects of antifungal drugs against Aspergillus species in the presence of serum. Antimicrob Agents Chemother 2013; 57: 1625-31.
44. Gloede J, Scheerans C, Derendorf H et al. In vitro pharmacodynamic models to determine the effect of antibacterial drugs. J Antimicrob Chemother 2010; 65: 186-201.
45. Pfaller MA, Andes D, Arendrup MC et al. Clinical breakpoints for voriconazole and Candida spp. revisited: review of microbiologic, molecular, pharmacodynamic, and clinical data as they pertain to the development of species-specific interpretive criteria. Diagn Microbiol Infect Dis 2011; 70: 330-43.
46. Fraczek MG, Bromley M, Buied A et al. The cdr1B efflux transporter is associated with non-cyp51A-mediated itraconazole resistance in Aspergillus fumigatus. J Antimicrob Chemother 2013; 68: 1486-96.
47. da Silva Ferreira ME, Capellaro JL, dos Reis Marques E et al. In vitro evolution of itraconazole resistance in Aspergillus fumigatus involves multiple mechanisms of resistance. Antimicrob Agents Chemother 2004; 48: 4405-13.
48. Smith J, Safdar N, Knasinski V et al. Voriconazole therapeutic drug monitoring. Antimicrob Agents Chemother 2006; 50: 1570-2.
49. Espinel-IngroffA, Johnson E, Hockey H et al. Activities of voriconazole, itraconazole and amphotericin B in vitro against 590 moulds from 323 patients in the voriconazole Phase III clinical studies. J Antimicrob Chemother 2008; 61: 616-20.
50. Imhof A, Balajee SA, Fredricks DN et al. Breakthrough fungal infections in stem cell transplant recipients receiving voriconazole. Clin Infect Dis 2004; 39: 743-6.
51. Giannella M, Munoz P, Guinea J et al. Growth of Aspergillus in blood cultures: proof of invasive aspergillosis in patients with chronic obstructive pulmonary disease? Mycoses 2013; 56: 488-90.